FDA Enforcement and Recall Report Week of May 16
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.
Anyone subscribing to the FDA recall e-mail list received saw only a small slow down in the barrage of FDA food recall notices related to the frozen food recall. This past week the recall notices continued as part of the frozen food recall connected to CRF Foods. A total of 28 recall notices posted – that is only a reduction of 7 notices compared to last week.
Typically FDA food recall notices involve undeclared allergens. This has been the case the past three weeks. A Listeria outbreak linked to CRF Foods impacting 358 products across 42 brands. The Listeria recalls constituted a full 64% of the recall notices (18 of the 28).
Undeclared allergens came in second with 4 of the 28 (a very small number compared to most weeks), four other pathogen recalls, a quality control recall due to over salting and a hazard recall and one Sildenafil recall in a dietary supplement rounded out the list.
A busy week demonstrating how interconnected the food supply chain can be. One key feature of FSMA is supplier verification and integration of the supply chain. A recall notice like CRF Foods highlights why supplier verification became a key component of FSMA.
The frozen food recall will likely contninue to generate notices for the next week or two.
FDA Warning Letters
FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve no letters from center for tobacco for Family Smoking Prevention violations. This is unusual compared to most weeks.
A full five (5) letters were issued for Good Manufacturing Practice (GMP or cGMP) issues. A week like this emphasizes how GMP issues are not confined to the FDA Form 483.
Similar to last week one warning letter was issued for claims leading to reclassification as a new drug. This week a warning letter designated several products as new drugs for express and implied disease claims. Also interest to note a warning letter last week due to Sildenafil or analogs of Sidenafil. This connects with the recall from a separate company also related to Sildenafil. This is a common issue with dietary supplements, in particular male enhancement supplements.
Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.
FDA Recalls May 6 – May 13
|05/13/2016||Fresh Attractions, 1897, Ciao, Farmers Market, more||Trail Mix||Listeria monocytogenes||HMSHost|
|05/13/2016||Hy-Vee||Fried Rice||Listeria monocytogenes||Hy-Vee, Inc.|
|05/13/2016||The Farmers Market||Chopped Asian Salad Kit||Undeclared Almonds, Soy and Wheat||Fresh Express|
|05/13/2016||Productos Del Campo Castillo||Habanero Peppers||Salmonella||Montero Farms|
|05/12/2016||Piggly Wiggly||Yellow Cut Corn||Listeria monocytogenes, CRF2016||McCall Farms Inc.|
|05/11/2016||Whole Foods Market||Korean BBQ Sauce||Undeclared peanuts and tree nuts (coconut)||Whole Foods Market|
|05/11/2016||Vending Nut Company||Sunflower kernel products||Listeria monocytogenes||Vending Nut Company|
|05/10/2016||Nature’s Promise, Woodstock, Market Basket, Woodfield Farms||Walnuts and walnut-containing products||Listeria monocytogenes||United Natural Trading LLC dba Woodstock Farms Manufacturing|
|05/10/2016||Frontier Co-op||Organic Hojicha Tea||Salmonella||Frontier Co-op|
|05/10/2016||Trader Joe’s||Kale & Edamame Salad||Salmonella||WCD Kitchen, LLC|
|05/10/2016||Simple Truth||Organic mixed vegetables||Listeria monocytogenes, CRF2016||The Kroger Co.|
|05/10/2016||Publix||Cranberry nut and seed mix||Listeria monocytogenes||Publix Super Markets|
|05/10/2016||Tiger-X, Ninja-X, Ginseng Power-X, Super Samurai-X||Marketed as a dietary supplement||Products contain Sildenafil, and analogs of Sildenafil||SOS Telecom, Inc.|
|05/09/2016||Natural Directions||Organic Mixed Vegetables and Organic Green Peas||Listeria monocytogenes, CRF2016||NORPAC Foods, Inc.|
|05/09/2016||Uncle Bucks||Sweet & Salty Trail Mix||Listeria monocytogenes||Rucker’s Wholesale and Service Co.|
|05/09/2016||Let’s Talk Health||“Energizer Drink Mix,” Agua Vitae Liquid Multi-Vitamin, Agua Vitae Kids Liquid Multi-Vitamin and Tox-Elim||Undeclared milk and soy||Let’s Talk Health, Inc.|
|05/09/2016||Kroger||Broccoli Raisin Salad||Listeria monocytogenes||The Kroger Co.|
|05/09/2016||Pictsweet||Frozen Vegetables||Listeria monocytogenes, CRF2016||The Pictsweet Company|
|05/09/2016||Dollywood||Sweet & Salty Trail Mix||Listeria monocytogenes||Rucker’s Makin’ Batch Candies, Inc.|
|05/07/2016||Tai Pei, Trader Joe’s, Hy-Vee, more||Frozen foods||Listeria monocytogenes, CRF2016||Ajinomoto Windsor, Inc.|
|05/07/2016||Kroger, P$$T||Frozen Vegetables||Listeria monocytogenes, CRF2016||The Pictsweet Company|
|05/06/2016||Central Market Organic, HEB, Sweetfrost and Woodstock||Vegetable Products Containing Organic Peas||Listeria monocytogenes, CRF2016||Twin City Foods, Inc|
|05/06/2016||Pulmuone||Korean Noodles||Undeclared Milk||Pulmuone Foods USA|
|05/06/2016||Watts Brothers Farms, Trader Joe’s||Frozen vegetable products||Listeria monocytogenes, CRF2016||ConAgra Foods|
|05/06/2016||Harris Teeter||Frozen Organic Corn and Frozen Mixed Vegetables||Listeria monocytogenes, CRF2016||Harris Teeter|
|05/06/2016||Stahlbush||IQF Green Beans||Listeria monocytogenes||Stahlbush Island Farms, Inc.|
|05/06/2016||Manna Pro||Chick Starter Medicated||May contain excessive salt||Manna Pro Products, LLC|
|05/06/2016||Dorothy Lynch Home Style Dressing||Dorothy Lynch Home Style Dressing||Bacteria (lactobacillus)||Tasty Toppings, Inc.0|
FDA Warning Letters as of 5/16/16
|May 04, 2016||Corey Kay||Kansas City District Office||Illegal Drug Residue||Not Issued *|
|May 02, 2016||Summit Beverage Group, LLC||Baltimore District Office||CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated||Not Issued *|
|April 29, 2016||PharmaLogic CSP, Inc.||Baltimore District Office||CGMP/Compounded Drugs/Misbranding||Not Issued *|
|April 28, 2016||Macular Health||New Orleans District Office||New Drug/Misbranded||Not Issued *|
|April 27, 2016||Riddhi USA Inc.||New York District Office||CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated||Not Issued *|
|April 27, 2016||Service First Pharmacies Inc, dba Madison Drugs||New Orleans District Office||CGMP/Compounded Drugs/Misbranding||Not Issued *|
|April 26, 2016||S & S Foods, Inc.||Dallas District Office||Acidified Foods/Emergency Permit Control/Adulterated||Not Issued *|
|April 25, 2016||Faye’s Texas Naturals||Dallas District Office||Acidified Foods/Emergency Permit Control/Adulterated||Not Issued *|
|April 21, 2016||Hartley Medical Center Pharmacy, Incorporated||Los Angeles District Office||CGMP/Compounded Drugs/Misbranding||Not Issued *|
|Apotheca Supply, Inc||04/07/2016||New Orleans District Office||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||No|
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation right now.